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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT01740583 |
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Date of registration:
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30/11/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation
ALIGN |
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Scientific title:
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A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation |
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Date of first enrolment:
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November 2012 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01740583 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Colombia
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France
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Paraguay
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Poland
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Contacts
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Name:
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Adrian Ebner, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanatorio Italiano (The Italian Hospital) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- NYHA II-IV
- Structurally normal mitral valve
- At least Grade 2 mitral regurgitation
- Left ventricular ejection fraction not less than 20% and not greater than 45%
- Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5
cm
Exclusion Criteria:
- Pregnant or lactating female
- Mitral stenosis
- Mod/severe aortic stenosis or regurgitation
- Mod/severe tricuspid stenosis or regurgitation
- Endocarditis
- Previous mitral valve repair or MV replacement
- Bioprosthetic or mechanical aortic valve
- Known unstable angina or MI within 30 days prior to procedure
- CVA within past 6 months
- Known contraindications to blood transfusion, contrast dye, DAPT
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mitral Valve Regurgitation
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Intervention(s)
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Device: percutaneous annuloplasty
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Primary Outcome(s)
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Major Adverse Events (MAE)
[Time Frame: within 30 days post procedure]
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Secondary Outcome(s)
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Echocardiographic Outcomes
[Time Frame: at 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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